Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anfibatide Injection in Healthy Volunteers

NCT07887490 | Not Yet Recruiting Phase 1

• 1 other identifier: ZK052-LEES-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of Recombinant Anfibatide Injection in healthy adult volunteers. Approximately 36 healthy participants will receive a single intravenous dose of either study drug or matching placebo across sequential dose cohorts. Safety, tolerability, and pharmacokinetic parameters will be assessed following administration.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)

  Safety and tolerability assessed by the incidence, severity, and relationship of adverse events, graded per NCI CTCAE v6.0, including abnormal laboratory values, vital signs, ECG, and physical examination findings.

  From dosing through Day 8 follow-up visit

Secondary Outcomes (9)

• Time to Maximum Observed Concentration (Tmax) of Recombinant Anfibatide

  Pre-dose through 48 hours post-dose

• Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)

  Pre-dose through 48 hours post-dose

• Maximum Observed Concentration (Cmax) of Recombinant Anfibatide

  Pre-dose through 48 hours post-dose

• Platelet Aggregation Inhibition Rate (Ristocetin-induced)

  Pre-dose through 48 hours post-dose

• Glycoprotein Ib (GP-Ib) Receptor Binding Rate

  Pre-dose through 48 hours post-dose

Study Arms (2)

Recombinant Anfibatide Injection

EXPERIMENTAL

Recombinant Anfibatide Injection, single intravenous dose.

Drug: Recombinant Anfibatide Injection

Placebo

PLACEBO COMPARATOR

Matching placebo injection

Other: Placebo

Interventions

Placebo OTHER

Matching placebo injection

Placebo

Recombinant Anfibatide Injection DRUG

Recombinant Anfibatide Injection is a polypeptide antithrombotic agent. Administered as a single intravenous bolus injection over approximately 5 minutes.

Recombinant Anfibatide Injection

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female participants aged 18-45 years;
• Body weight: body mass index = weight (kg)/height² (m²) within 19.0-26.0 (inclusive), and body weight ≥50 kg;
• Participants are in generally good health without a history of significant disease, with normal findings on physical examination, vital signs, 12-lead ECG, and laboratory tests. If abnormal, the clinical judgment that the findings are clinically insignificant permits participation in the clinical trial;
• Participants volunteer to participate and sign the informed consent form;
• Participants of childbearing potential have no plans for pregnancy, sperm donation, or egg donation from two weeks before screening of this study until 6 months after the end of the trial, and voluntarily take appropriate contraceptive measures.

You may not qualify if:

• Any clinically significant medical history or disease
• Conditions that may increase bleeding risk (e.g., bleeding disorders, recent surgery, abnormal coagulation parameters)
• History of hypertension, syncope, or convulsions
• HBV, HCV, HIV, or syphilis infection
• Drug or alcohol abuse
• Recent participation in another clinical trial or blood donation
• Pregnancy or breastfeeding
• Hypersensitivity to study drug components
• Use of any medications within 14 days prior to dosing

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 15, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)